FDA overhauls 510(k) process

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The FDA issued two evaluations containing recommendations that address three objectives of the agency’s public health mission as it relates to medical devices--foster device innovation, create a more predictable regulatory environment and enhance device safety.

The FDA’s Center for Devices and Radiological Health (CDRH) assessment consists of two preliminary reports. One report focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The other evaluates CDRH’s use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.

CDRH established two staff committees on these issues in late 2009 as part of its 2010 strategic plan, according to the agency. The committees collected and reviewed input from public meetings, open dockets, data analyses and input from CDRH staff over the course of several months to prepare the complementary evaluations.

“Even with our significant outreach, it’s important to remember that these recommendations are preliminary,” said CDRH Director Jeffrey Shuren, MD. “CDRH opened another public docket to receive additional comments on both reports. We will make a decision on which recommendations to adopt only after a thorough review of additional comments.”

The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), noted that further study will be required to understand the implications of the recommendations, but added that “a number of them have the potential to make the clearance process more rational and predictable; a long-held goal of manufacturers. However, others, if implemented incorrectly, have the potential to hinder patient access to life-saving technologies.”

Specifically, for regulatory predictability, the 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination. This guidance would seek to clarify what information submitters should include in their 510(k) submissions, the FDA said.

The science report recommended use of a standardized “notice to industry” letter that would generally be issued as a "level 1 - immediately in effect" guidance document to communicate when CDRH has changed its premarket regulatory expectations due to scientific information that has emerged about a certain device type. CDRH currently communicates this kind of information through individual interactions during the review process, which can lead to delays. The agency predicts that these letters would provide greater clarity to affected manufacturers, in a timelier manner, about CDRH’s expectations with respect to a particular group of devices.

Also, for patient safety, the 510(k) report recommended that CDRH develop a guidance document that clarifies when a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns, the agency said. The report recommended that the center consider issuing a regulation that would clarify the circumstances under which the center would exercise its authority to rescind a 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate, and also consider whether additional authority is needed.

Both reports recommended that CDRH build on public databases to include up-to-date information that supports decision making and promotes the safe use of devices. In addition, the science report recommends that CDRH build on the existing transparency website to provide more immediate information on how devices are regulated.